The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients

AceTech120 enrolled

Overview

Radiation dermatitis (RD) is one of the most common side effects of Radiation therapy (RT) and 95% of patients receiving RT may experience some form of radiation dermatitis. A wide variety of topical, oral, and intravenous agents are used to prevent/treat Radiation dermatitis but currently there is no gold standard in the prevention and management of this condition and no treatment can be explicitly recommended. RadiaAce Gel is a wound dressing Hydrogel (Acemannan Hydrogel) for the management of RD which provides optimal moist wound environment necessary to the healing process. Based on its composition as well as the supporting data on safety and performance of the functional ingredient Acemannan in wound healing, RadiaAce may well be suited to complement the prevention and therapy of radiation dermatitis. The primary aim of the study is to evaluate the safety and performance of RadiaAce as compare to Biafine in reducing the proportion of breast cancer patients that experience grade 2 or higher RD as measured by the RTOG scoring system

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Breast Cancer Radiation Dermatitis

RadiaAce gelDEVICE

Patients will apply the RadiaAce to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.

BiafineDEVICE

Patients will apply the Biafine to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female patients 2. Age \> 18 3. Patients with histologically-confirmed diagnosis of breast cancer 4. Patients after breast lumpectomy and that scheduled to receive radiotherapy 5. Patients to receive minimum of 40.05 Gy to primary field 6. Must be able to comply with treatment schedule 7. Study-specific signed informed consent prior to randomization Exclusion Criteria: 1. Inflammatory or connective tissue disorders of the skin 2. Mental incompetence, including psychological or addictive disorders which would preclude completion of questionnaires 3. Previous radiation therapy to the breast 4. Tumour involvement of the skin 5. Rash, ulceration or open wound in treatment field 6. Known skin allergy or sensitivity to Aloe Vera or Biafine 7. Current lactation 8. Pregnancy 9. Any other reason that, in the opinion of the investigator, prevents the subject from

Outcomes

Primary Outcomes

Skin assessment (RD grade)

Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring

Time frame: 10 weeks

Pain (VAS)

Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment

Time frame: 10 weeks

Patient's assessment of the skin condition (DLQI questioner)

The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)

Time frame: 10 weeks

The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts